Diabetes Testing

Credit: Accu-chek.com

The Accu-Chek Aviva was first in an evaluation of a dozen meters conducted by a team of testing experts at Germany’s University of Ulm led by Guido Freckmann, M.D. It led the field in accuracy and precision.

Few studies of meter accuracy have appeared in the more than 20 years that I have been writing about diabetes. Dr. Freckmann and his team of researchers have been the most relevant, reliable, and prolific in testing our meters. But some of the meters that they evaluated aren’t available in the United States.

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The most important tool for most of us who have diabetes is our blood glucose meter. But usually we have no idea how inaccurate they are.

In the United States the organization responsible for setting the standards for meter accuracy is the Food and Drug Administration. This is one of the FDA’s most important roles for people with diabetes because if our blood glucose gets too low we can fall into a coma, and if it goes to high we are more likely to get one or more of the awful complications of uncontrolled diabetes.

But few of us know what the standards are, judging from the messages that people with diabetes send me and what I read on the Internet. For years I have been writing about the need for our meters to be more accurate, but as I explored this key topic in depth I got more and more confused and told my friend Bennet Dunlap that.

Used with permission of DiabetesMine.com

“The more confused you are the more you understand status quo,” he replied. Bennet is perhaps our leading diabetes advocate and has addressed the FDA directly on this issue. Bennet created Strip Safely and together with another diabetes patient advocate, Christel Marchand Aprigliano, co-founded the Diabetes Patient Advocacy Coalition.

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You probably never use the control solution for your blood glucose meter. You can blame your doctor or yourself for this oversight, but the chances are that you never have heard this term before.

Our doctors and other medical professionals rarely discuss using a control solution. It usually doesn’t come with our blood glucose meters. And your local drug store probably doesn’t carry the one that your meter uses.

But the U.S. Food and Drug Administration, the International Organization for Standardization (ISO),  and the American Diabetes Association all recommend that we often check our meter with its control solution.  Probably every owner’s manual for all of the blood glucose meters on the market has the same message. Something is seriously out of whack here.

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For years the usual way that we got diagnosed with diabetes was a fasting plasma glucose test. But there are two other ways that we get the news now.

The newest way is when a doctor told us the results of a glycosylated hemoglobin test, which we usually call simply an A1C test. While a few of us learned that we have diabetes after we had an oral glucose tolerance test, that has always been the least common diagnostic tool for diabetes.

The blue circle is the universal symbol for diabetes

The quickest and easiest is clearly the A1C test. But it has several limitations on its accuracy. In fact, none of these three ways that our doctors diagnose diabetes is perfect.

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Of the four companies that dominate the blood glucose meter business in the United States, we are happiest with Roche Diagnostics, according to a new scientific survey. Number two was Abbott Laboratories, third was Bayer, and pulling up last was LifeScan.

But two of the particular meters that LifeScan makes rank among the three favorite meters. Those few people in the survey who use the OneTouch UltraLink or the OneTouch Vario liked it a lot as did the small sample size of people who rated Bayer’s Contour Next Link.

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It seems logical that the lower our blood glucose levels are the better we will be. Most of us have always assumed that lower blood glucose levels would protect us better from the complications of diabetes. In fact, during the past two decades several studies showed a linear relationship between blood glucose, as measured by A1C levels, and worsened health.

But now, several recent A1C studies have shown a J-shaped relationships, in which at the lower end some bad things happen, at the center things are better, and at the top end things are terrible. While linear relationships are the rule in observational studies, U-shaped and J-shaped curves aren’t uncommon, and some authors lump both of these shapes as U-shaped.

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